Delving into the Latest Updates on BN-104 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BN 104, BN104

Target

menin

Action

inhibitors

Mechanism

menin inhibitors(Menin inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Refractory acute myeloid leukemiaAcute Promyelocytic LeukemiaAdult Acute Lymphocytic Leukemia+ [3]

Inactive Indication-

Originator Organization

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

Active Organization

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

RegulationFast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China)

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主要目的：评价健康受试者在空腹和进食高脂餐后单次口服BN104片的药代动力学特征以及食物对BN104片药代动力学特征的影响。次要目的：1）评价健康受试者在空腹和进食高脂餐后单次口服BN104片后的安全性和耐受性；2）初步评估BN104对QTc间期的影响。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of BN104 tablets after a single oral administration on an empty stomach and after a high-fat meal in healthy subjects and the effect of food on the pharmacokinetic characteristics of BN104 tablets. Secondary objectives: 1) To evaluate the safety and tolerability of BN104 tablets after a single oral administration on an empty stomach and after a high-fat meal in healthy subjects; 2) To preliminarily evaluate the effect of BN104 on the QTc interval.

Start Date08 Jan 2025

Sponsor / Collaborator

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

NCT06746519

/ RecruitingPhase 1/2IIT

A Phase I/II , Multicenter, Open Label Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of the Combination of the Menin Inhibitor BN104 for the Treatment of Patients With Acute Myeloid Leukemia

The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.

Start Date25 Dec 2024

Sponsor / Collaborator

The First Affiliated Hospital of Soochow University

[+1]

NCT06724549

/ Not yet recruitingPhase 1

A Study to Evaluate the Effect of Food on the Pharmacokinetics of BN104 Tablets in Healthy Subjects

The goal of the clinical trial is to evaluate the effect of food on the Pharmacokinetics of BN104 tablets in healthy subjects. The main questions it aims to answer are:
* Whether the pharmacokinetic characteristics of BN104 tablets will be affected by food?
* How well is the safety and tolerability of BN104 tablets in healthy subjects?
* To preliminarily evaluate the effect of BN104 on the QTc interval.
Participants will:
* Be randomized into Group I or Group II with equal numbers in each group.
* Receive the investigational drug either under fasting conditions or after consuming a high-fat meal in each period.
* be treated only once per period.

Start Date20 Dec 2024

Sponsor / Collaborator

BioNova Pharmaceuticals (Shanghai) Ltd.Startup

100 Clinical Results associated with BN-104

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100 Translational Medicine associated with BN-104

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100 Patents (Medical) associated with BN-104

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1

News (Medical) associated with BN-104

20 Apr 2023

·www.bionovapharma.com

BN104 Granted Orphan Drug Designation by US FDA for the Treatment of Acute Myeloid Leukemia

SHANGHAI, China, April. 20, 2023 - BioNova Pharmaceuticals Limited (BioNova), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to BN104 for the treatment of acute myeloid leukemia (AML).

Orphan Drug

100 Deals associated with BN-104

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	25 Dec 2024
Acute Promyelocytic Leukemia	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	19 Oct 2023
Adult Acute Lymphocytic Leukemia	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	19 Oct 2023
Refractory Acute Leukemia	Phase 2	China	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	16 Oct 2023
Recurrent Acute Leukemia	IND Approval	United States	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	21 Sep 2023
Acute Myeloid Leukemia	Preclinical	United States	BioNova Pharmaceuticals (Shanghai) Ltd.Startup	17 Apr 2023